A Comparison of the Safety, PD and PK of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

164

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

December 31, 2017

Study Completion Date

January 31, 2018

Conditions
Human Rabies
Interventions
BIOLOGICAL

SYN023

The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.

BIOLOGICAL

Imovax

Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine

BIOLOGICAL

RabAvert

Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine

BIOLOGICAL

HyperRAB ST (human rabies immune globulin)

The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.

Trial Locations (1)

33136

inVentiv Clinical Research Facility, 1951 NW 7th Ave. Suit 450, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

inVentiv Health Clinical

OTHER

lead

Synermore Biologics Co., Ltd.

INDUSTRY